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NCT06331494

Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

Summary

Ischemic stroke with high incidence, mortality, disability and recurrence rate, has become the leading threat to the health worldwide. Intracranial atherosclerotic stenosis (ICAS) is commonly associated with ischemic stroke, especially in Chinese residents. Patients with severe ICAS are subject to a very high risk of recurrent stroke events, despite best medical therapy available. Unstable or complex atherosclerotic plaques can lead to plaque ruptures and distal embolisms, thereby increasing the risk of ischemic stroke recurrence. Studies have shown that activation of inflammatory states may play a driving role in the formation and development of atherosclerosis. So far, it remains unclear which are the best treatments for this condition, especially for high-risk patients. Dl-3-n-butylphthalide (NBP) is a Class I novel drug independently developed in China and was officially approved for use in acute ischemic stroke. Preclinical data showed that NBP can act multiple effects of anti-inflammation, antioxidation and anti-apoptosis by suppressing pro-inflammatory factors and upregulating the expression of anti-inflammatory factors. It is still undetermined whether combined therapy with NBP could enhance the curative effect of intracranial atherosclerosis. The primary purpose of this trial is to evaluate the efficacy of butylphthalide in reducing the degree of arterial stenosis and stabilizing plaques in patients with severe symptomatic middle cerebral artery stenosis.

Official title: Efficacy of Butylphthalide on Symptomatic Atherosclerotic Stenosis in Middle Cerebral Artery (SICAS): a Prospective, Randomized, Double-blinded, Placebo-controlled, Multiple-center Trial.

Key Details

Gender

All

Age Range

55 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-03-15

Completion Date

2026-08-31

Last Updated

2024-03-26

Healthy Volunteers

Conditions

Ischemic Stroke, Acute Intracranial Atherosclerosis

Interventions

DRUG

Butylphthalide

Butylphthalide Sodium Chloride injection for 10±3 days, oral Butylphthalide soft capsules for day 11±3 to day 180.

DRUG

Placebo

Butylphthalide Placebo injection for 10±3 days, oral Butylphthalide Placebo soft capsules for day 11±3 to day 180.

Inclusion Criteria: 1. Female or male aged 55-75 years; 2. At least one of the following risk factors of atherosclerosis: hypertension, diabetes, hypercholesterolemia, or smoking; 3. Symptomatic atherosclerotic stenosis in middle cerebral artery: large artery atherosclerotic cerebral infarction or TIA within 7 days of onset; 70%-99% stenosis of the responsible middle cerebral artery \[M1\] confirmed by high-resolution MRI examination (referred to Warfarin-Aspirin Symptomatic Intracranial Disease standard); new-onset infarction confirmed by diffusion weighted imaging (DWI) or TIA symptoms in the territory of the responsible artery supply; 4. NIHSS ≤ 20; 5. mRS ≤ 2 at randomization (pre-morbid historical assessment); 6. Participants understand the purpose of the study and have signed informed consent form. Exclusion Criteria: 1. Presence of intracranial hemorrhage or other pathological brain diseases; 2. Plan to or have performed intravenous thrombolysis or mechanical thrombectomy therapy; 3. Unable to undergo MRI examination; 4. Use Butylphthalide during onset between randomization; 5. Suspect of cardiac embolism, such as atrial fibrillation, artificial heart valves, endocarditis, etc; 6. Contraindications for the use of clopidogrel or aspirin; 7. Known allergy history of celery or butylphthalide; 8. Severe liver dysfunction (aspartate aminotransferase or alanine transaminase \> 2 times normal upper limit) or severe renal dysfunction (creatinine value \> 1.5 times normal upper limit), heart failure, asthma, etc; 9. History of intracranial hemorrhage, coagulation disorders, systemic bleeding, thrombocytopenia, or other hematological disorders; 10. Plan to perform other surgical procedures or interventional treatments that may require termination of investigational drug use; 11. Severe non-cerebrovascular diseases with an expected survival time less than 3 months; 12. Actively participating in another drug or device trial; 13. Use any drugs with the same or similar mechanism as Butylphthalide during the follow-up period; 14. Unsuitable for this trial from the opinion of the investigators.

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China